Self-monitoring and Reflection's Impact on Psychotherapy Outcomes: A Trial Protocol.

Psychological Clinical Trial

Official title:

Investigating the Impact of Regular Self-monitoring and Reflecting on Affective Reactions Toward the Psychotherapist on Treatment Outcomes: A Randomized Controlled Trial Protocol.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06038747
• Other study ID #: 23-1067
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Alberto Stefana, PhD
• Phone: +393381131304
• Email: astefana[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this randomized controlled trial is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes.

Description:

The quality of the therapeutic relationship is critical in determining psychotherapy outcomes. However, facilitating patients' self-awareness and reflection on their affective responses to their therapist remains understudied as a potential tool for enhancing this relationship and subsequent treatment outcomes. The primary objective of this study is to examine the influence of a brief post-session battery, designed to foster patient self-monitoring and reflection on their emotional reactions toward their psychotherapist, on the quality of the therapeutic relationship and treatment outcomes. Using an observational randomized control trial design, participants will be allocated into intervention and control groups. Those in the intervention group will complete a postsession battery following each therapy session, while the control group will only undergo regular treatment. Data collection will be facilitated through the Qualtrics online survey software and span baseline, mid-trial (5th week), and end-of-trial (10th week) assessments.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• being aged 18 years or older,
• being fluent in English,
• being currently under individual psychotherapy with a minimum frequency of two sessions per month.

Exclusion Criteria:

• having a legal guardian.

Related Conditions & MeSH terms

• Psychological
• Psychotherapy
• Therapeutic Alliance

Intervention

Other:
• Self-Monitoring
The post-session battery consists of two self-report scales measuring both positive and negative affective reactions of the participants toward their therapist during the therapy session. The general feedback is a brief text that encourages participants to share and discuss their feelings and reflections with their therapist.
• Individual Psychotherapy
Individual psychotherapy sessions

Locations

Country	Name	City	State
United States	Researchforme.Unc.Edu	Chapel Hill	North Carolina
United States	Researchmatch.Org	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	European Commission, University of Pavia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 5 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.	Baseline, 5 weeks
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from baseline to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.	Baseline, 10 weeks
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Total score) from 5 weeks to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a 34-item self-report measure of change in psychotherapy. Total score ranges 0-136. Higher scores represent poorer overall functioning.	5 weeks, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 5 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.	Baseline, 5 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from baseline to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.	Baseline, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Subjective well-being deficits) from 5 weeks to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The subjective well-being subscale score ranges 0-16). Higher scores represent poorer subjective well-being.	5 weeks, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 5 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.	Baseline, 5 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from baseline to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.	Baseline, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Problems/symptoms) from 5 weeks to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The problems/symptoms subscale score ranges 0-48). Higher scores represent greater problems/symptoms.	5 weeks, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 5 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.	Baseline, 5 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from baseline to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.	Baseline, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Life functioning difficulties) from 5 weeks to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The life functioning difficulties subscale score ranges 0-48). Higher scores represent greater life functioning difficulties.	5 weeks, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 5 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.	Baseline, 5 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from baseline to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.	Baseline, 10 weeks.
Primary	Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (Risk/harm) from 5 weeks to 10 weeks	Measure of psychological distress devised to be administered during a course of psychotherapeutic treatment to determine treatment response. The Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of change in psychotherapy. The risk/harm subscale score ranges 0-26). Higher scores represent greater risk/harm.	5 weeks, 10 weeks.
Secondary	Real Relationship Inventory-Client-Short form (Total score)	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. Total score ranges 0-40. Higher scores represent better quality of the real relationship. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Real Relationship Inventory-Client-Short form (Genuineness)	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Genuineness subscale (3 items) score ranges 0-20. Higher scores represent higher perceived genuineness. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Real Relationship Inventory-Client-Short form (Realism)	Measure of the real relationship between a therapist and participant from the participant's viewpoint. The Real Relationship Inventory-Client-Short form (RRI-C-SF) is an 8-item self-report measure of the quality of the real relationship and includes two subscales: Genuineness and Realism, both of which represent closely related dimensions of authenticity and perceptual accuracy within the therapeutic relationship. The Realism subscale (4 items) score range 0-20. Higher scores represent higher perceived realism. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Working Alliance Inventory-Short Revised (Total score)	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance and includes three subscales: goal, task, and bond. Total score ranges 0-72. Higher scores indicate a stronger alliance. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Working Alliance Inventory-Short Revised (Goal)	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Goal subscale (3 items) score ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Working Alliance Inventory-Short Revised (Task)	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Task subscale score (3 items) ranges 0-18. Higher scores indicate a stronger agreement on the tasks of therapy. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Working Alliance Inventory-Short Revised (Bond)	Measure of the working alliance between a therapist and participant from the participant's viewpoint. The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item self-report measure of the quality of the working alliance. The Bond subscale score (3 items) ranges 0-18. Higher scores indicate a stronger affective bond between the patient and the therapist. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.
Secondary	Number of sessions missed or canceled	Number of scheduled psychotherapy sessions that have been missed or canceled by the participant. It will be assessed at baseline, mid-trial (5 weeks), and end-of-trial (10 weeks).	Up to 10 weeks.